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Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

Primary Purpose

Chronic Eczema

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Runzao zhiyang capsule
Runzaozhiyang capsule agent simulation
Urea cream
Sponsored by
Guizhou Tongjitang Pharmaceutical Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Eczema focused on measuring chronic eczema, efficacy and safety, Runzao zhiyang capsule

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consistent with diagnostic criteria for chronic eczema(Referring to "the Chinese eczema diagnosis and treatment guidelines" in 2011);
  • Investigator Global Assessment (IGA) score was 2 or 3;
  • The skin lesions were localized, hypertrophy and dry, and the affected skin area was 3%~10% of body surface area (estimated by palm method); the diameter of target lesions was 2~10cm and located in the limbs or trunk.
  • The course of chronic eczema is more than 6 months;
  • Age 18 to 70, males or females;
  • The Subjects obtain informed consent, participated the trial voluntarily. Procedure to obtain informed consent is in accordance with the provisions of Good Clinical Practise(GCP).

Exclusion Criteria:

  • Subjects with acute eczema, subacute eczema, universal eczema, special type of eczema;
  • Subjects used corticosteroids, immunosuppressive agents and ultraviolet irradiation in 4 weeks prior to the enrollment;
  • Subjects were treated with antihistamine and topical drugs in 2 weeks;
  • Women in Pregnancy, Lactation, or Planned pregnancy during the test;
  • Comorbid with severe primary heart, liver, lung, kidney, blood disease, diabetes, thyroid disease or a serious disease affecting survival, such as cancer or HIV / AIDS;
  • Subjects were allergic to test drug ingredients;
  • Subjects could not give full informed consent because of mental and behavioral disorders;
  • Suspected or identified with a history of alcohol or drug abuse;
  • Have other diseases or conditions which may reduce the possibility of enrollment or complicate the recruiting process based on the investigator judgment. For example, working environment changed frequently led to easily lost follow-up;
  • Have been or currently enrolled in other clinical trials within 3 months.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Beijing Friendship Hospital,Capital Medical UniversityRecruiting
  • The First Affiliated Hospital of Chongqin Medical UniversityRecruiting
  • Sun Yat-Sen Memorial Hospital,Sun Yat-Sen UniversityRecruiting
  • The Second Xiangya Hospital of Central South University
  • Dermotology hospital, Chinese academy of medical scienceRecruiting
  • Dermatology Hospital in Shandong ProvinceRecruiting
  • Rui Jin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
  • Huashan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Runzao zhiyang capsule

Runzaozhiyang capsule agent simulation

Arm Description

Runzao zhiyang capsule: 4 pills each time, 3 times a day, oral， Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.

Runzaozhiyang capsule agent simulation:4 pills each time, 3 times a day, oral, Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.

Outcomes

Primary Outcome Measures

The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100%

Secondary Outcome Measures

The decrease rate of EASI in each visit compare with baseline
Changes in the degree of pruritus（test by visual analogue scale） in the follow-up visits compared with baseline
DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline.
The proportion of patients (EASI score greater than 10% of the patients before treatment)
EASI score

Full Information

First Posted
October 9, 2015
Last Updated
September 19, 2016
Sponsor
Guizhou Tongjitang Pharmaceutical Co.,Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02601222
Brief Title
Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema
Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trials to Evaluate the Efficacy and Safety of Runzao Zhiyang Capsule in Treating Chronic Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guizhou Tongjitang Pharmaceutical Co.,Ltd
Collaborators
Beijing Bionovo Medicine Development Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
Detailed Description
Polygoni multiflori Preparata, dried rehmannia root, mulberry leaf, sophora flavescens, Honghuoma, for skin itching, acne, constipation due to blood vacuity and wind-dryness, also used in clinical treatment of eczema. The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Eczema
Keywords
chronic eczema, efficacy and safety, Runzao zhiyang capsule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Runzao zhiyang capsule
Arm Type
Experimental
Arm Description
Runzao zhiyang capsule: 4 pills each time, 3 times a day, oral， Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.
Arm Title
Runzaozhiyang capsule agent simulation
Arm Type
Placebo Comparator
Arm Description
Runzaozhiyang capsule agent simulation:4 pills each time, 3 times a day, oral, Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day.
Intervention Type
Drug
Intervention Name(s)
Runzao zhiyang capsule
Intervention Description
Runzao zhiyang capsule：4 pills each time, 3 times a day, oral. Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
Intervention Type
Drug
Intervention Name(s)
Runzaozhiyang capsule agent simulation
Intervention Description
Runzaozhiyang capsule agent simulation：4 pills each time, 3 times a day, oral， Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
Intervention Type
Drug
Intervention Name(s)
Urea cream
Intervention Description
Topical application, apply to the affected area and gently rub, 2 times a day.Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
Primary Outcome Measure Information:
Title
The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100%
Time Frame
0,4 weeks
Secondary Outcome Measure Information:
Title
The decrease rate of EASI in each visit compare with baseline
Time Frame
0,2,4,8,12 weeks
Title
Changes in the degree of pruritus（test by visual analogue scale） in the follow-up visits compared with baseline
Time Frame
0,2,4,8,12 weeks
Title
DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline.
Time Frame
0,2,4,8,12 weeks
Title
The proportion of patients (EASI score greater than 10% of the patients before treatment)
Time Frame
8,12 weeks
Title
EASI score
Time Frame
8,12 weeks
Other Pre-specified Outcome Measures:
Title
Safety assessments will be based on adverse event reports.
Time Frame
2,4,8,12 weeks
Title
Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests.
Time Frame
0,2,4，8，12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consistent with diagnostic criteria for chronic eczema(Referring to "the Chinese eczema diagnosis and treatment guidelines" in 2011); Investigator Global Assessment (IGA) score was 2 or 3; The skin lesions were localized, hypertrophy and dry, and the affected skin area was 3%~10% of body surface area (estimated by palm method); the diameter of target lesions was 2~10cm and located in the limbs or trunk. The course of chronic eczema is more than 6 months; Age 18 to 70, males or females; The Subjects obtain informed consent, participated the trial voluntarily. Procedure to obtain informed consent is in accordance with the provisions of Good Clinical Practise(GCP). Exclusion Criteria: Subjects with acute eczema, subacute eczema, universal eczema, special type of eczema; Subjects used corticosteroids, immunosuppressive agents and ultraviolet irradiation in 4 weeks prior to the enrollment; Subjects were treated with antihistamine and topical drugs in 2 weeks; Women in Pregnancy, Lactation, or Planned pregnancy during the test; Comorbid with severe primary heart, liver, lung, kidney, blood disease, diabetes, thyroid disease or a serious disease affecting survival, such as cancer or HIV / AIDS; Subjects were allergic to test drug ingredients; Subjects could not give full informed consent because of mental and behavioral disorders; Suspected or identified with a history of alcohol or drug abuse; Have other diseases or conditions which may reduce the possibility of enrollment or complicate the recruiting process based on the investigator judgment. For example, working environment changed frequently led to easily lost follow-up; Have been or currently enrolled in other clinical trials within 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gu heng, M.D.
Phone
+86-25-85478045
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gu heng, M.D.
Organizational Affiliation
Dermotology hospital, Chinese academy of medical science
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Sen, M.D.
Phone
+86-551-62922016
Facility Name
Beijing Friendship Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Linfeng, M.D.
Phone
+86-10-63138628
Facility Name
The First Affiliated Hospital of Chongqin Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Hui, M.D.
Phone
+86-25-85478045
Facility Name
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeng Fanqin, M.D.
Phone
+86-20-81332371
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Qianjin, M.D.
Phone
0731-85292097
Facility Name
Dermotology hospital, Chinese academy of medical science
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gu Heng, M.D.
Phone
025-85478045
Facility Name
Dermatology Hospital in Shandong Province
City
Ji nan
State/Province
Shandong
ZIP/Postal Code
250022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Furen, M.D.
Phone
+86-531-87298884
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Jie, M.D.
Phone
+86-21-54661789
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Jinhua, M.D.
Phone
+86-21-52888045

12. IPD Sharing Statement

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Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

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